FDA-Device2026-04-01Class IIPROCESSING DEFECT
Olympus OER-Pro endoscope reprocessor incompatible with MAJ-1443 and MAJ-1444 adapters
OTHERNationwide distribution
Check your Olympus endoscope reprocessor compatibility
Olympus has identified that two adapter models (MAJ-1443 and MAJ-1444) are no longer compatible with OER-Pro and OER-Elite automated endoscope reprocessors. This means these adapters cannot be safely used with these reprocessing machines. No injuries have been reported.
- If you use an OER-Pro or OER-Elite reprocessor, verify whether you have MAJ-1443 or MAJ-1444 adapters.
- Do not use MAJ-1443 or MAJ-1444 adapters with your OER-Pro or OER-Elite reprocessor.
- Contact Olympus or your equipment representative for compatible replacement adapters or instructions.
Hazard
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Sold states
US Nationwide distribution.
Affected count
3,354 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1613-2026More Olympus Corporation of the Americas recalls
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